{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-161",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-161.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/161",
  "kind": "regulation",
  "number": "161",
  "heading": "Written representations procedure",
  "text": "(1) If a recipient makes written representations in accordance with regulation 160(2)(a) the licensing authority must appoint a panel of at least two persons (“the reviewers”) to advise on the provisional determination.\n(2) The licensing authority must provide the reviewers with—\n(a) the recipient's written representations; and\n(b) any written representations of the licensing authority.\n(3) The reviewers must advise the licensing authority on the authority's provisional determination taking account of—\n(a) the written representations; and\n(b) any other evidence submitted to them.\n(4) The licensing authority must take into account the reviewers' advice and make a final determination as to whether the product is a medicinal product.\n(5) The licensing authority must—\n(a) inform the recipient in writing of its final determination and of the reasons for it; and\n(b) if the licensing authority disagrees with the reviewers' advice, inform the recipient in writing of the reasons for that disagreement.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/161",
    "retrieved_at": "2026-10-29T01:24:34.993203+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}